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Arteriopathy and Endothelial Function

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ClinicalTrials.gov Identifier: NCT00487617
Recruitment Status : Unknown
Verified February 2009 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
First Posted : June 18, 2007
Last Update Posted : February 25, 2009
Sponsor:
Information provided by:
University Hospital, Strasbourg, France

Brief Summary:
To determine whether fruit juice might reverse endothelial dysfunction and whether this reversibility has a prognosis value

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Procedure: Fruit juice or placebo absorption Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Endothelial Dysfunction Reversibility in Patients With Peripheral Arterial Disease
Study Start Date : July 2007
Estimated Primary Completion Date : October 2011
Estimated Study Completion Date : April 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: fruit juice
300 mL of fruit juice
Procedure: Fruit juice or placebo absorption
absorption of 300 ml of fruit juice ; 24 hours later, absorption of 300 ml of placebo.

Placebo Comparator: placebo
300 mL of fruit juice without polyphenols
Procedure: Fruit juice or placebo absorption
absorption of 300 ml of fruit juice ; 24 hours later, absorption of 300 ml of placebo.




Primary Outcome Measures :
  1. Endothelial function 1 hour after taking the juice [ Time Frame: 1 hour after taking the juice ]

Secondary Outcome Measures :
  1. Relationship between reversibility of the endothelial function and the patient's prognosis at 3 years [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Peripheral arteriopathy
  • Stable cardio-respiratory status

Exclusion Criteria:

  • Dialysis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00487617


Contacts
Contact: Olivier Rouyer, MD 33.3.88.11.61.22 olivier.rouyer@chru-strasbourg.fr

Locations
France
Service de Chirurgie Vasculaire Recruiting
Strasbourg, France, 67091
Contact: Fabien Thaveau, MD    33.3.88.11.60.68    fabien.thaveau@chru-strasbourg.fr   
Principal Investigator: Fabien Thaveau, MD         
Sub-Investigator: Nabil Chakfe, MD         
Sub-Investigator: Jean-Georges Kretz, MD         
Service de Physiologie et d'Explorations Fonctionnelles Recruiting
Strasbourg, France, 67091
Contact: Olivier Rouyer, MD    33.3.88.11.61.22    olivier.rouyer@chru-strasbourg.fr   
Principal Investigator: Olivier Rouyer, MD         
Sub-Investigator: Bernard Geny, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Study Director: Olivier Rouyer, MD Hôpitaux Universitaires de Strasbourg

Responsible Party: Christine GEILLER, Direction de la Recherche Clinique et de l'Innovation - Hôpitaux Universitaires de Strasbourg
ClinicalTrials.gov Identifier: NCT00487617     History of Changes
Other Study ID Numbers: 3801
First Posted: June 18, 2007    Key Record Dates
Last Update Posted: February 25, 2009
Last Verified: February 2009

Keywords provided by University Hospital, Strasbourg, France:
Arteriopathy
endothelial function
fruit juice

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases